Long-term Safety and Efficacy Study of Octreotide Implant in Patients With Acromegaly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01295060
Recruitment Status : Terminated (Program was terminated for business reasons)
First Posted : February 14, 2011
Last Update Posted : September 20, 2013
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief Summary:
This is a long term study to evaluate the safety, tolerability and efficacy of an Octreotide Implant in patients that were previously treated with an Octreotide implant.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: Octreotide Phase 3

Detailed Description:
Evaluation on the long-term safety and tolerability, including local tolerability of the implant site, of the 84-mg octreotide hydrogel implant in subjects with acromegaly who had been successfully treated with the 84-mg octreotide hydrogel implant in the Phase III study IP107-001.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Octreotide Implant Drug: Octreotide
84 mg Octreotide Implant

Primary Outcome Measures :
  1. Long term safety and tolerability of the Octreotide Implant [ Time Frame: every 3 months for up to 2 years ]
    Subjects will be assessed every 3 months via adverse event reporting and examination of the implantation site

Secondary Outcome Measures :
  1. Evaluate the long term efficacy of the Octreotide Implant [ Time Frame: every 3 months for up to 2 years ]
    Patients will have GH and IGF-1 analyzed every 3 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Currently enrolled in the Extension Phase of Study IP107-001 and received at least one 84-mg octreotide hydrogel implant prior to enrollment OR previously enrolled in the Extension Phase of Study IP107-001 and currently taking lanreotide or octreotide.
  • Subjects who have been successfully treated with the 84-mg octreotide hydrogel implant in Study IP107 001.
  • In the opinion of the Investigator; subject has no unstable chronic medical conditions and no clinically significant findings that would preclude subject's participation in the study.
  • Subjects must be able to communicate, provide and sign written informed consent, and be willing to participate and comply with study requirements.

Exclusion Criteria:

  • Pituitary surgery less than 3 months prior to enrollment into this study
  • Liver disease (eg, cirrhosis, chronic active or persistent hepatitis or persistent abnormalities of ALT, AST [level >2× normal] or direct bilirubin [level >1.5× normal])
  • Unstable angina, sustained ventricular arrhythmias or heart failure (NYHA III and IV)
  • Acute myocardial infarction within 3 months of Screening
  • Uncontrolled diabetes defined as having an HbA1c ≥9%
  • Symptomatic cholelithiasis
  • History of drug or alcohol abuse
  • Received any investigational drug or participated in another clinical trial except for study IP107 001 within 30 days of enrollment into this study
  • Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any time prior to enrollment into this study
  • Receiving pegvisomant, dopamine agonist or other therapy in combination with somatostatin to control GH or IGF-1 levels prior to enrollment into this study
  • History or presence of significant cardiovascular, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, any other severe coexisting or, terminal systemic disease that limits life expectancy, or may interfere with the conduct of the study, or subjects who are incarcerated in penal institutions or are committed to mental institutions
  • Women who are pregnant or lactating. For females of childbearing potential, a positive pregnancy test prior to enrollment, or an unwillingness to use accepted forms of reliable birth control for study duration (including bilateral tubal ligation, use of oral contraceptives, double barrier methods [diaphragm with spermicidal gel or condoms with contraceptive foam], Depo-Provera®, hormonal implants, partner vasectomy, and total abstinence). Pregnancy tests are not required (indicate "n/a") for males, or for females not of childbearing potential (post-menopausal with last menstrual period >1 year ago or total hysterectomy with bilateral oophorectomy)
  • An unwillingness on the part of a male subject to abstain from sexual intercourse with pregnant or lactating women or an unwillingness to use a condom and spermicide and another form of contraception (eg, IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant until discharge from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01295060

United States, Colorado
Denver, Colorado, United States, 80220
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Maryland
Baltimore, Maryland, United States, 21215
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Oregon
Portland, Oregon, United States, 97239
United States, Washington
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Endo Pharmaceuticals

Responsible Party: Endo Pharmaceuticals Identifier: NCT01295060     History of Changes
Other Study ID Numbers: EN3332-301
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: September 2013

Keywords provided by Endo Pharmaceuticals:
Growth Hormone

Additional relevant MeSH terms:
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents